NCT04153942撤回3 期
Earlier Mobilization Post Acute Thrombolysis
Brian Silver0 个研究点开始时间: 2023年8月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- 90 day mRS
研究概览
简要总结
This is a phase III trial trying to determine whether 12-hour bed rest following IV thrombolysis therapy (i.e. tPA) for ischemic stroke is non-inferior to 24-hour bed rest by measure of outcomes on the modified Rankin Scale (mRS) at 90 days post bed rest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors blind to the subject's treatment/arm will do the evaluations at 90 days
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Received intravenous tPA for a clinical diagnosis of acute ischemic stroke
- •Patient and/or Legally Authorized Representative provide consent
排除标准
- •Venous thromboembolism present at symptom onset
- •Pneumonia present at symptom onset
- •STEMI at symptom onset
- •Positive troponins at symptom onset according to local values
- •Bone fracture at symptom onset
- •Treatment includes or anticipated to include thrombectomy
- •Intubation anticipated or occurred
- •Symptomatic intracranial hemorrhage (defined as increase in NIHSS by 4 points or more accompanied by PH2 hemorrhage on imaging) at the time of screening.
- •Pre-screening systolic blood pressure < 110 mmHg
- •Resting pulse oximetry < 92% (with or without supplemental oxygen)
- •Neurological worsening (defined as NIHSS increase of 4 points compared to initial score) prior to screening.
- •Baseline modified Rankin Scale score > 2
- •Known pregnancy
- •Patient not anticipated to survive 3 months
- •Patient not anticipated to follow-up at 3 months
结局指标
主要结局
90 day mRS
时间窗: 90 days post bed rest
Proportion of patients with a modified Rankin Scale score (min 0, max 5 with 0 being best outcome) of 0-2 at 90 days
次要结局
- Pneumonia(Duration of hospitalization stay, average 5 days)
- Venous Thromboembolism(Duration of hospitalization stay, average 5 days)
- Neurological Worsening(Duration of hospitalization stay, average 5 days)
- Length of Stay(Duration of hospitalization stay, average 5 days)
- Readmission(90 days post bed rest)
研究者
Brian Silver
Principal Investigator
University of Massachusetts, Worcester
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